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A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04161976
Recruitment Status : Recruiting
First Posted : November 13, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The main purpose of this study is to learn more about a new formulation of insulin lispro when given by an insulin pump to participants with type 1 diabetes mellitus. The study will investigate how the body processes the drug and how the drug affects the body. Information about side effects will be collected. The study will last from six to 12 weeks for each participant.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: LY900027 Drug: Insulin Lispro Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900027 in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy
Actual Study Start Date : December 27, 2019
Estimated Primary Completion Date : July 20, 2020
Estimated Study Completion Date : July 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: LY900027
LY900027 administered to participants with type 1 diabetes mellitus (T1DM) using continuous subcutaneous insulin infusion (CSII) in one of two dosing periods.
 Drug: LY900027
LY900027 administered to participants with T1DM using CSII.
Active Comparator: Insulin Lispro
Insulin lispro administered to participants with T1DM using CSII in one of two dosing periods.
 Drug: Insulin Lispro
Insulin lispro administered to participants with T1DM using CSII.
Other Names:
  • Humalog
  • LY275585


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics (PK): Pharmacokinetics (PK): Area Under the Insulin Lispro Curve (AUC) 0 to 5 hours after Bolus Administration Prior to a Mixed Meal Tolerance Text (MMTT) [ Time Frame: Day 1 through Day 10 in each dosing period ]
    PK: AUC after Bolus Administration Prior to a MMTT

  2. PK: Maximum Observed Insulin Lispro Concentration (Cmax) [ Time Frame: Day 1 through Day 10 in each dosing period ]
    PK: C PK: Cmax


Secondary Outcome Measures :
  1. Pharmacodynamics (PD): Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion [ Time Frame: Day 1 through Day 10 in each dosing period ]
    PD: Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion

  2. PD: Total Daily Insulin Dose [ Time Frame: Day 1 through Day 10 in each dosing period ]
    PD: Total Daily Insulin Dose

  3. Duration Until Catheter Failure [ Time Frame: Day -1 through Day 10 in each dosing period ]
    Duration Until Catheter Failure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of T1DM for at least 1 year
  • Fasting C-peptide ≤0.30 nanomoles per liter (nmol/L)
  • Bbody mass index between 18.5 and 33.0 kilograms per square meter (kg/m²)
  • Participants should have a glycated hemoglobin of ≤9.0% at screening

Exclusion Criteria:

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04161976


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Germany
Profil Institut für Stoffwechselforschung Recruiting
Neuss, Nordrhein-Westfalen, Germany, 41460
Contact    49213140180      
Principal Investigator: Oliver Klein         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04161976    
Other Study ID Numbers: 17489
J2H-MC-IUAA ( Other Identifier: Eli Lilly and Company )
2019-002318-37 ( EudraCT Number )
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs